Medical Device and Pharmaceutical Product Development and Compliance

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Our blog navigates product development and compliance for the life science industry. Our solutions save time and money, delivering products with less risk.

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Medical Device | Product Development | reusability

Reusability: Data Duplication to Accelerate Medical Device Development

By: Bradley Sylvestre
September 14th, 2021

Key takeaway: The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market. Time equates to money in any business, and in the world of medical device design and manufacturing, that can mean BIG numbers! Depending on the route taken, following FDA regulations, the average cost to bring a medical device to market through the Premarket Approval pathway is $94 million. The less intensive 510(k) process averages out at $31 million.

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